Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis Risk
- Sponsor
- University of Salerno
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Parathyroid hormone (pg/mL)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water
Investigators
Luca Rastrelli
Principal Investigator Full Professor Luca Rastrelli
University of Salerno
Eligibility Criteria
Inclusion Criteria
- •Premenopausal women aged ≥40 years
- •Menopausal women, period of early menopause 1-10 years
Exclusion Criteria
- •Inclusion in other study protocols
- •estrogen-replacement hormone therapy
- •osteoporosis therapy
- •corticosteroid therapy
- •insulin therapy.
- •calcium supplementation
- •kidney diseases of medium-severe level
- •liver diseases of medium-severe level
- •severe osteoporosis
Outcomes
Primary Outcomes
Parathyroid hormone (pg/mL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
calcium (mg/dL)
Time Frame: 0-3-6 month
change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests
25-OH vitamin D (ng/mL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
osteocalcin (ng/mL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
Secondary Outcomes
- NMR metabolomic profile and applications of Metabolomics in calcium metabolism(0-3-6 month)